Regulatory Environment

Mexican health regulation is strict, despite the impressions of international media when an innovative procedure is performed in the country. Headed by COFEPRIS, an agency that regulates 10.9 percent of Mexican trade, 9.8 percent of GDP and 44 cents of every peso spent by Mexican households, the regulatory sector in Mexico has expanded in recent years. It now includes authorized third parties, who are legally able to perform analysis of pharmaceuticals and medical devices for the regulator and thus speed up the approval process for new products. In 2017, a new type of authorized third party was created for publicity, to grant marketing approvals for products regulated by COFEPRIS.

Navigating the rules and regulations can prove to be a challenge for multinational companies, as they differ from those encountered in other regions, but an array of consultants and lawyers specialized in the Mexican health industry is at hand to help companies with the intricacies of doing business in Mexico.

This chapter will include insightful interviews with the key regulatory players and those who specialize in this area.

-> How does Mexican regulation balance the need for safety with quick access to products?